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A 16-day, randomized, double-blind, double-dummy, placebo-controlled, parallel-group trial comparing lumiracoxib 100mg o.d. with naproxen 500 mg b.i.d. plus omeprazole 20mg o.d. and placebo in healthy...

Mise à jour : Il y a 4 ans
Référence : EUCTR2005-005422-31

A 16-day, randomized, double-blind, double-dummy, placebo-controlled, parallel-group trial comparing lumiracoxib 100mg o.d. with naproxen 500 mg b.i.d. plus omeprazole 20mg o.d. and placebo in healthy volunteers to confirm the safety and tolerability of lumiracoxib in the small bowel

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Extrait

The primary objective of this study is to demonstrate, by video capsule endoscopy (VCE), that the percentage of subjects with one or more small bowel mucosal breaks (with or without hemorrhage) is significantly lower for lumiracoxib than for naproxen + omeprazole.

Critère d'inclusion

  • Healthy Volunteers

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